Tissue repair implant and delivery device and method

ABSTRACT

A device for the repair of tissue and methods of use and manufacturing thereof are described herein. Applications for the use of the device include, e.g., repair of atrial septal defects (ASD), patent foramen ovale (PFO), left atrial appendage closure and stent graft fixation among other applications throughout the anatomy. The implant portion of the device is available in a variety of sizes and configurations to accommodate the vast complexity of the target anatomy.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of and claims the benefit of the filingdate of U.S. patent application Ser. No. 13/010,766, filed Jan. 20,2011, which claims the benefit of U.S. Provisional Patent ApplicationSer. No. 61/296,868, filed on Jan. 20, 2010, each of which is expresslyincorporated herein in its entirety by reference thereto.

Further, each of the following is hereby incorporated in its entirety byreference thereto: U.S. patent application Ser. No. 13/010,777, filed onJan. 20, 2011, U.S. patent application Ser. No. 13/010,774, filed onJan. 20, 2011; and U.S. patent application Ser. No. 13/010,769, filed onJan. 20, 2011.

FIELD OF THE INVENTION

The present invention relates to a tissue repair implant and deliverydevice and method.

BACKGROUND INFORMATION

Some surgical interventions require the repair of tissue, e.g., closureof the tissue or graft fixation. These procedures may include, forexample, treatment of atrial septal defects (ASD), patent foramen ovale(PFO), left atrial appendage closure, stent graft fixation, and herniarepair, among others.

ASDs and PFOs are considered to be two of the leading contributors toembolic stroke. Stroke is the third leading cause of death in the UnitedStates and one of the leading causes of adult disability. It isestimated that 80% of strokes are preventable and that repair ofexisting ASDs and PFOs will reduce the incidence. When ASDs and PFOs arepresent in the heart, a debilitating condition may occur. Deoxygenatedblood may pass from the right atrium through either the ASD and/or PFOinto the oxygenated blood of the left atrium. It has been estimated thatapproximately one in four individuals in the general population have aPFO. Individuals who have unknown causes of stroke (cryptogenic stroke),have a 40 percent increase in the likelihood of a PFO being present. PFOis even more prevalent in individuals who have had strokes under thatage of 55.

U.S. Pat. No. 7,220,265 describes a device for closure of PFO, wherein acatheter is directed into proximity of the PFO. The catheter is insertedbetween the septum primum and the septum secundum into the left atrium.The catheter then deploys a first closure member, e.g., a “grapplinghook element,” in the left atrium. The catheter is then drawn back intothe right atrium where a second closure member, e.g., a second grapplinghook element, is deployed. The first and second closure members areconnected by a central connecting member such that the septal tissuesare compressed together between the two opposed closure members. U.S.Pat. No. 7,220,265 also discloses a method of closing the PFO usingsutures, whereby implantable anchors purportedly limit the need for acontinuous thread. The devices and methods of U.S. Pat. No. 7,220,265require maneuvering of a medical device, e.g., a catheter or sutureneedle, in both the right and left atria. This may present substantialcomplexity and difficulty to the procedure, possibly increasing thelikelihood of surgeon error and/or increasing the time required tocomplete the procedure.

Further, typical existing anchors are configured to joining soft tissueto hard tissue, since there is no way to take out the slack with softtissue to soft tissue joining.

Thus, there is a need for a closure mechanism and method that is simpleto operate and only requires access to one side of the tissue ortissues. Further, there is a need for a reliable closure that may beprecisely located.

Moreover, some tissue defects, e.g., some heart defects and inguinalhernias, require the implantation of a mesh. In the example of aninguinal hernia, the mesh is intended to create a barrier againstabdominal cavity contents protruding through a defect the abdominalperitoneum and inguinal canal. A known treatment for such herniasinvolves applying a single anchor to a mesh, e.g., a square mesh, thenpulling the mesh taut and applying a second anchor to the mesh. Thissequential fastening and tightening is repeated until the mesh issecured over the defect. This method is procedurally costly and timeconsuming, however, and there is a risk that the mesh may not beproperly or sufficiently tautened, which could render the meshineffective in preventing the protrusion of the abdominal cavitycontents through the inguinal canal.

Thus, there is also need for an implanting mechanism and method thatallows for a quick and reliable securement of a mesh to repair a tissuedefect, e.g., allowing for simultaneous application of fasteners.

Further, there is a need for a mechanism and method that reducesprocedural costs and allows access to difficult-to-reach locations ofthe anatomy.

SUMMARY

According to example embodiments of the present invention, a device forthe repair of tissue and methods of use and manufacturing of the deviceare provided. Applications for the use of the device include, e.g.,repair of atrial septal defects (ASD), patent foramen ovale (PFO), leftatrial appendage closure, stent graft fixation, and hernia repair, amongother applications throughout the anatomy. The implant portion of thedevice may be provided in a variety of sizes and configurations toaccommodate the vast complexity of the target anatomy.

Example embodiments of the present invention provide for an implant anda delivery device which may be used to bring adjacent tissues intoapproximation in order to provide a wide array of therapeutictreatments, including, e.g., repair of ASD, PFO, left atrial appendageocclusion, and stent graft fixation among many other applications in thehuman body, or, e.g., any suitable mammalian body.

According to example embodiments of the present invention, a fastenerhaving a distal end and a proximal end includes an elongated body havinga distal tip, and anchoring filaments extending radially outwardly fromthe elongated body in a proximal direction of the elongated body, theanchoring filaments configured to resist proximal movement of theelongated body when the fastener is driven in a distal direction intoone or more layers of tissue.

The fastener may also have a proximal head disposed proximally from theanchoring filaments, wherein the proximal head extends radiallyoutwardly from the elongated body and is configured to limit the depthto which the fastener is proximally driven into one or more layers oftissue.

The proximal head may be fixed to the elongated body.

The proximal head and the elongated body may be formed together as asingle monolithic piece.

The fastener may further include a proximal head configured to engage aproximal portion of the elongated body.

The proximal head may include threads that engage corresponding threadson the proximal portion of the elongated body when the proximal headengages the proximal portion of the elongated body, wherein rotation ofthe proximal head with respect to the threads of the proximal portion ofthe elongated body causes movement of the proximal head along thelongitudinal axis of the elongated body.

The proximal head and the elongated body together form a ratchet whenthe proximal head engages the proximal portion of the elongated body,wherein the proximal head is moveable distally along the elongated bodyand restrained from proximal movement along the elongated body.

The fastener may be formed partially or entirely of, e.g., abio-absorbable material.

The distal tip may be tapered. The distal tip may be blunt or taper to asharp point. The distal tip may be a cutting tip. The distal tip mayinclude at least one concave tapered cutting edge. The distal tip mayinclude three concave tapered cutting edges. The three concave taperedcutting edges may be equidistant from each other around a circumferenceof the fastener. The distal tip may be a reverse-cutting tip.

According to example embodiments of the present invention, a surgicaldevice for implanting a fastener having proximally directed anchoringfilaments includes a device body and a fastener driver coupled to thedevice body and configured to penetrate a first soft tissue, engaging anunsupported second soft tissue, and anchoring the fastener in the secondsoft tissue so that the fastener can bring the second soft tissue indirect apposition to the first soft tissue.

The fasteners are preferably driven at a speed greater than 50 metersper second, more preferably in a range of 50 to 350 meters per second,and most preferably at 350 meters per second. However, it should beunderstood that the fasteners may be driven at any suitable speedsufficient for the fasteners to puncture tissue.

The fastener driver may be configured to drive the fastener at apredetermined distance and velocity based on a determined distancebetween the first tissue and the second tissue. The fastener driver isadjustable to drive the fastener at different distances and velocitiesbased on the determined distances between the first tissue and thesecond tissue. The fastener driver may be configured to impart amomentum to the fastener sufficient to drive the fastener through thefirst soft tissue and into the second soft tissue. The fastener drivermay be configured to transfer hydraulic force to the fastener to impartthe momentum. Saline may be provided for the hydraulic propulsion.

The surgical device may further include the fastener, wherein theanchoring filaments of the fastener are configured to resist proximalmovement of the fastener when the fastener is driven through the firstsoft tissue and into the second soft tissue.

The fastener may include a proximal head and the fastener driverincludes a plurality of flanges configured to contact a distal face ofthe proximal head to limit the depth to which the fastener is driven bythe fastener driver.

The flanges may be radially expandable from each other to release theproximal head of the fastener.

The fastener may be attached to a suture.

According to example embodiments of the present invention, a surgicaldevice comprises a fastener including an elongated body having aproximal end and a distal tip, and a filament secured to the fastenerand extending from the proximal end of the elongated body.

The filament may be a braided filament.

The device may be formed by coextrusion of the fastener over thefilament.

The fastener may further include anchoring filaments proximallyextending from the elongated body, the anchoring filaments configured toresist proximal movement of the elongated body when the fastener isdriven in a distal direction into one or more layers of tissue. Thefastener and the filament may be comprised of a bio-absorbable material.

The distal tip of the fastener may be blunt. The distal tip of thefastener may taper to a sharp point. The distal tip may be tapered. Thedistal tip may be a cutting tip. The distal tip may include at least oneconcave tapered cutting edge. The distal tip may include three concavetapered cutting edges. The three concave tapered cutting edges may beequidistant from each other around a circumference of the fastener.

The distal tip may be a reverse-cutting tip.

According to example embodiments of the present invention, a surgicaldevice comprises a fastener including a proximal end and a distal tip,the fastener configured to anchor into a tissue when distally driveninto the tissue, a filament secured to the fastener and extending fromthe proximal end of the elongated body, and a fastener driver coupled tothe device body and configured to distally drive the fastener into thetissue.

The filament may be a braided filament.

The distance to which the fastener is driven may be limited by apredetermined amount of slack in the filament prior to the driving, thedistance being limited by the tautening of the filament.

The fastener may include proximally extending anchoring filamentsconfigured to anchor the fastener into the tissue. The fastener drivermay be configured to drive the fastener into through a first tissue andinto a second tissue such that the fastener anchors in the secondtissue. The first and second tissues may be soft tissues, the fastenerdriver being configured to impart a momentum to the fastener sufficientto drive the fastener through the first soft tissue and into the secondsoft tissue when the second soft tissue is unsupported. The fastenerdriver may be configured to drive the fastener at a predetermineddistance and velocity based on a determined distance between the firsttissue and the second tissue. The fastener driver may be adjustable todrive the fastener at different distances and velocities based on thedetermined distances between the first tissue and the second tissue. Thefastener driver may be configured to drive the fastener using ahydraulic propulsion. Saline may be provided for the hydraulicpropulsion.

The surgical device may further comprise a capstan configured toproximally reel the filament after the fastener has been driven by thefastener driver.

The proximal reeling of the filament may cause a corresponding proximalmovement of the tissue when the fastener is anchored in the tissue.

The fastener may be molded to the filament. The fastener may becoextruded with the filament. The filament may be a braided filament.The fastener may include a plurality of molded radially disposedanchoring filaments.

According to example embodiments of the present invention, a surgicaldevice comprises an elongated fastener body, and wings disposed on adistal portion of the fastener body, wherein the body has externalcorrugations and the wings have external corrugations.

According to example embodiments of the present invention, a method ofpurposefully bringing two adjacent tissues together includes, theplacement of a delivery system device in approximation of the tissue,creating surface tension with the device, and ejecting an absorbable ornon-absorbable implant from the device. The device controls the exactplacement of the implant, which penetrates both tissues thus creatingcontact between the two tissue surfaces so that the two tissues are inapproximation.

According to example embodiments of the present invention, an absorbableor non-absorbable implant has a needle-like tip tapering to a bodyportion that contains filaments protruded therefrom, the filamentspresent over a percentage of the length of the body. The implant maytransition from the portion with filaments to a threaded section for,e.g., the remaining percentage of the length of the body. The threadedsection is capable of receiving a nut and/or head which can moveindependently from the body of the implant. The head is able to beindependently rotated so that the head can compress the two previouslypenetrated adjacent tissues to bring them into apposition.

According to example embodiments of the present invention, a deviceincludes a housing and a firing pin disposed in the housing and axiallymovable in the housing. The device also includes a spring coupled to thehousing and the firing pin to apply a spring force between the housingthe firing pin. The housing includes a distal portion configured toreceive an implant. The device includes at least one of a cable and ashaft, the at least one of a cable and shaft being configured toreleasably attach to a proximal end of the firing pin and to pull thefiring pin to a proximal position, thereby increasing a force exertedbetween the spring and the housing. The at least one of a cable and ashaft is configured to release the firing pin from the proximal positionto allow the firing pin to move distally forward in response to thespring force. The distal motion of the firing pin causes the firing pinto extend into the distal portion of the housing.

The device may include two or more implants in an end-to-endarrangement.

The device may be configured to cause only the distal-most of the two ormore implants to be ejected when the firing pin extends into the distalportion after being released by the at least one of a cable and a shaft.

The device may include a sleeve disposed in the housing, the sleeveconfigured to move the firing pin and spring to a second, more distallocation within the housing in order to drive the next of the two ormore implants.

According to example embodiments of the present invention, an implantdriving device includes a housing and a driving shaft disposed in thehousing and axially movable and rotatable in the housing. The housingincludes a distal portion that houses two or more implants in anend-to-end arrangement, the two or more implants being drivable by theaxial movement and rotation of the driving shaft.

The proximal-most of the two or more implants may have a recess thatmates with a corresponding projection of the driving shaft.

Each of the two or more fasteners may have distal end portions having ageometry that mates with a proximal recess of each of the other of thetwo or more fasteners.

Two or more, e.g., all, of the fasteners may be driven simultaneously,or substantially simultaneously.

The fasteners may be driven in a plurality of sets, each set of anchorsbeing driven simultaneously, or substantially simultaneously.

Further features and aspects of example embodiments of the presentinvention are described in more detail below with reference to theappended Figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of two surgical implants.

FIGS. 2A and 2B are schematic illustrations of surgical implants withdriving mechanisms.

FIG. 3 is a schematic illustration of a surgical implant with a drivingmechanism.

FIG. 4 is an illustration of a surgical implant.

FIG. 5A is an illustration of a surgical implant.

FIG. 5B is a cross-sectional view of the surgical implant of FIG. 5A.

FIGS. 6A to 6C schematically and sequentially illustrate the bringinginto apposition of two tissues using a surgical implant.

FIG. 7 is an illustration of a surgical implant.

FIG. 8 is an illustration of a distal end portion of a surgical implant.

DETAILED DESCRIPTION

FIG. 1 is an illustration of two surgical micro implants or fasteners100 and 200. The surgical implants 100 and 200, which may be absorbableor non-absorbable, are designed to penetrate and join two adjacentviscera or tissue planes. The implants 100 and 200 are designed to passthrough the first tissue and the second tissue under controlled rapiddeployment. The implant is shaped similarly to a needle with apredetermined geometry. Each implant 100, 200 has an elongated body 105,205 that tapers in a distal region to a needle-like tip 110, 210. Eachimplant 100, 200 may be deployed, as described in greater detail below,by being pushed from a precisely placed hollow needle or tube containingthe implant 100, 200. The implants disclosed herein may be formed usinge.g., micromachining techniques.

The micro implants 100 and 200, as well as any other implants disclosedherein may have a diameter of one millimeter, or approximately onemillimeter, and a length that is in a range from 5 millimeters to 10millimeters. According to some example embodiments, the diameter is lessthan one millimeter. According to some example embodiments, the diameteris in a range from 0.8 millimeters to 1.2 millimeters. It should beunderstood, however, that other dimensions may be provided.

The body 105, 205 of each implant 100, 200 has specifically designedmicro anchoring filaments 115, 215 which arise from a core 120, 220 ofthe implant 100, 200 to extend outwardly from the core 120, 220. Theanchoring filaments 115, 215 are located around the circumference andalong at least a portion of the length of the body 105, 205 of theimplant 100, 200. This allows the implant to resist removal once it haspenetrated the tissue.

The filaments 115, 215, or any other filaments described herein may haveany suitable dimensions. For example, it may be advantageous to providea filament tip (i.e., free end) diameter of 0.1 millimeters and taperingtoward a diameter of 0.25 millimeters at the body.

The core 120, 220 has a constant diameter along a substantial length ofthe body 105, 205 of the implant 100, 200. For example, the core 120 ofthe implant 100 has a constant cross-section, and constant diameter,from a head portion 125 to a substantially conically shaped taperedportion toward the tip 110. It should be understood however, that theimplants 100 and 200 may have a more continuous taper and/or have aconstant or non-constant rate of taper.

The anchoring filaments 115, 215 extend outwardly at an angle withrespect to the longitudinal axis of the implant 100, 200. In thisregard, the filaments, in addition to extending outwardly away from thelongitudinal axis, also extend in a proximal direction, away from thetip 110, 210. This allows for the filaments 115, 215 to slide along thepierced tissue during distal driving or insertion. However, proximalmovement of the implants 100, 200 from the inserted position isprevented or resisted by engagement of the outer, free ends of thefilaments 115, 215 with the relatively soft tissue. The filaments 115,215 may be flexible or substantially rigid. The filaments 115, 215should, however, have sufficient stiffness or strength to resistproximal withdrawal of the implant 100, 200 from the inserted position.Further, although the filaments 115, 215 are illustrated as beingstraight, it should be understood that some or all of the filaments 115,215 may be at least partially curved, and/or have one or more bendsbetween straight portions and/or curved portions. Moreover, thefilaments 115, 215 of a given implant 100, 200 may have constant ordiffering lengths, radial extensions, and/or angles with respect to thelongitudinal axis of the implant 100, 200.

The filaments 115, 215, or any other anchoring filaments describedherein may be provided with any appropriate density and relativespacing, depending on the particular application. For a givenapplication, a greater density (i.e., a greater number of filaments perunit of surface area) of smaller filaments may be provided, or a lesserdensity of larger filaments (optionally reinforced with a shape memoryalloy, e.g., nitinol and/or spring-loaded steel), while presenting thesame or comparable suture retention or “pull through strength.” Theoptional reinforcement could be a “V” shaped portion formed of shapememory alloy, e.g., nitinol and/or spring-loaded steel. The filaments115, 215 may be absorbable or non-absorbable in whole or in part.

Each implant 100, 200 includes a proximal head 125, 225. The head 125,225 extends radially beyond the core 120, 220 and has a larger axialcross section than the core 120, 220. The head 125, 225 may prevent theimplant 100 from being driven too deeply into, or entirely through, thetissue. As the implant 100, 200 is driven distally along itslongitudinal axis, the core 120, 220 pierces into and progresses throughthe tissue. The head 125, 225, having a larger diameter or crosssection, prevents or resists the proximal portion of the implant 100,200 from extending into the tissue. Thus, where two layers of tissue arepierced and joined, the distal layer of tissue is constrained againstdistal movement away from the proximal layer of tissue by engagement ofthe distal layer with the filaments 115, 215, and the proximal layer isconstrained against proximal movement away from the distal layer byengagement of the proximal layer (e.g., the outer proximal surface ofthe proximal layer) with the head 125, 225.

The implant 100 differs from the implant 200 in that the implant 100 hasanchoring filaments 115 provided from the tip region to an axiallyfixed, proximal head 125, whereas the implant 200 has a predeterminedlength that is externally threaded with micro threads 230 to allow thehead 225, which has corresponding internal threads, to rotate about theimplant, thus bringing the two adjacent tissues into approximation. Inthis regard, the implant 200 may be initially driven into the tissue,the distance to which is driven being limited by, e.g., friction betweenthe implant 200 and the tissue. After the initial driving, the head 225may be rotated, e.g., in a clockwise direction, to move the head or nut225 distally along the longitudinal axis of the implant 200. Therotation may be performed by a rotatable driver having projectionsconfigured to engage driving recesses 227 of the head 225, as describedin greater detail below. Although the head 225 has four evenly spacedrecesses 227, it should be understood that any appropriate number ofrecesses 227 may be provided. Further, the micro tightening nut or head225 may have projections as an alternative or in addition to therecesses, the projections engageable by the driver to rotate the head225. Moreover, any other appropriate driving mechanism may be provided.For example, the driver may grip the outer surface of the head 225 toimpart rotation via friction, or the radially outwardly facing surfaceof the head 225 may have one or more flat surfaces engageable by thedriver.

Contact between the distal face of the head 225 and the proximal surfaceof the proximal layer of tissue would in turn cause the proximal layerof tissue to move toward the distal layer of tissue, which is axiallyconstrained by the filaments 215. The head 225 may be prevented fromrotating in the opposition direction by friction between the threads orany appropriate locking or securing mechanism, e.g., detents. During thetightening rotation of the head 225, the body 205 may be prevented fromrotating by the engagement of the filaments 215 with the tissue or anyother appropriate mechanism.

Each implant 100, 200 has a proximal surface 135, 235 via which adriving force may be applied. The proximal surface 135 of the implant100 corresponds to the proximal surface of the proximal head 125, whilethe proximal surface 235 of the implant 200 has a smaller diameter,which is the same or substantially the same as the diameter of the core220.

Although the implants 100, 200 have cores 120, 220 and heads 125, 225with circular cross sections, it should be understood that othercross-sections may be provided, e.g., rectangular, triangular, oval,polygonal, and/or any other regular or irregular shape. Further, itshould be understood that the anchoring filaments 115, 215 may be evenlyspaced apart or may have non-uniform spacing. Moreover, the filamentdensity, i.e., the number of the filaments 115, 215 per unit of surfacearea of the core 120, 220 may be constant, or may vary.

Modern manufacturing processes allow for near nano technologyapplications. This allows the implants 100, 200 to be manufactured in asize and complexity that may not have been possible in years past. Theimplant 100, 200 may be injection molded of either absorbable or nonabsorbable polymers and then processed to add the features of theprotruding filaments 115, 215 and the threaded features 227. The head225 of the implant 200 is manufactured separately and to the same orsimilar tolerances so that the interface between the implant threads 230and the head 225 of the implant 200 will thread precisely upon oneanother.

Although the implants 100 and 200 are formed of polymer, it should beappreciated that any appropriate material may used, e.g., metal or acomposite material.

The materials and methods of manufacturing the implants 100 and 200 areapplicable to any of the implants described herein.

In order to accurately penetrate adjacent tissues that are not held orsecured on a distal side, a rapid penetration of each layer of tissuemay be required in order to affect penetration of both tissue layers. Ifan implant 100, 200 is applied slowly, the tissue may be pushed distallyaway by the implant and/or needle without adequate penetration. Thus,some example delivery mechanisms eject the implant a relatively highvelocity. In some preferred examples, saline is used to pressurize thechannel within the catheter or needle at such a rate that the plungerwill eject the implant at the precise velocity. Other exampleembodiments utilize a spring-loaded mechanical mechanism to eject theimplant. Further example embodiments push the implant using long pushrods which run the length of the catheter. The ejection modality iscomputer-controlled. However, it should be understood that the ejectionmay be, e.g., operator-controlled. For example, the ejection force maybe predetermined and repeatable by a mechanical system, e.g., aspring-loaded system, which is triggered by an operator, e.g., asurgeon.

FIGS. 2A and 2B are schematic illustrations of surgical implants 300 and500 with driving mechanisms including catheters or needles 400 and 600.

Referring to FIG. 2A, implant 300 shares many features in common withimplants 100 and 200. Implant 300 differs, however, in that it includesreverse threads 330 and a proximal head 325 having a driving recess 327.The driving recess has a geometry that corresponds to a rotatable driver405 of the catheter 400, such that the driver 405 is insertable into therecess 327 to impart axial rotation to the implant 300. In this regard,rotation of the driver in a first direction 410 causes the driver torotate in the direction 410. Although the direction 410 is clockwise(when view from a proximal location), it should be appreciated that thedriver may be configured to rotate the implant 300 in thecounter-clockwise direction, e.g., where the threading is reversed. Thedriver is configured to progressively move distally along its axisduring driving to correspond to a distance which the implant is driven.The corresponding geometry of the driver 405 and the recess 327 may beselected to have any appropriate cross section, e.g., rectangular orhexagonal.

The catheter has, at a distal end portion, a pair of retention tabs 415.The retention tabs 415 have inner diameters that are less than thediameter of the proximal head 325 but greater than the diameter of theother, more distal portions of the implant 300. Thus, the retention tabsallow the distal portions of the implant 300 to be driven beyond thedistal end of the catheter and into tissue, but retains the head 325within the catheter. After the driving of the implant 300, the retentiontabs may be actuated radially outwardly away from each other to allowthe release of the head of the implant 300 and withdrawal of thecatheter 400 away from the implant site.

Referring to FIG. 2B, the catheter 600 shares many features in commonwith the catheter 400, including, e.g., retention tabs 615, but differsin that it includes a spring driver 605. The spring driver 605 imparts aspring force onto the proximal head 525 of the implant 500 to impart arapid movement from an initial proximal position to an extended distalposition. The spring driver 605 may have an initial preloaded positionthat is not in contact with the implant 500. Thus, the spring and/or adriver portion driven by the spring may build momentum prior to engagingthe implant 500. This may be suitable for imparting a more aggressiveacceleration to the implant 500. When the implant is able to achieve ahigh speed quickly, it is able to pierce a proximal face 551 of thetissue and penetrate across the thickness of the tissue to the distalface 552, rather than simply compressing the outer proximal surface 551of the tissue. This may be particularly suitable in allowing a systemthat does not require any initial structure on the back side of thetissue during the driving process.

FIG. 3 is a schematic illustration of a surgical implant 700 with adriving mechanism. The driving mechanism is a catheter 800 sharingfeatures with the catheters 400 and 600 described above, including,e.g., retention tabs 815, which are shown in their opened, or radiallyextended position, thereby allowing distal axial passage therethrough ofthe head 725 of the implant 700.

The implant 700 includes many features in common with the implants 100,200, 300, and 500 described above, but differs in that it includes aplurality of spring loaded tabs 702, which may be formed, e.g., of ashape memory alloy, e.g., nitinol or spring-loaded steel. Thespring-loaded tabs are maintained in their closed, or radially inward,position when the proximal free ends of the tabs 702 are axiallydisposed in the catheter 800 (in its closed position) and in the tissuethrough which the tabs are driven after piercing of the tissue,including a proximal face 751, by the needle-like tip 710. However, whenthe proximal ends of the spring loaded tabs 702 clear the distal side752 of the tissue, the tabs are no longer radially constrained by thetissue and are able to spring radially outwardly into their openposition. In the open position, the implant 700 is prevented orconstrained from being proximally withdrawn through the tissue viacontact between the extended tabs 702 and the distal surface 752 of thetissue. The nut or head 725 of the implant 700 may then be rotated anddistally advanced as described above with regard to the head 225 of theimplant 200 in order to bring the layers of tissue together.

The driver may be configured to drive the any of the fasteners describedherein to a predetermined depth. The precision of the depth may beaccomplished by any appropriate mechanism, e.g., a precise hydraulicdriving force, engagement with flanges or other similary stops, or afilament/suture that tautens to limit the depth. Further the depth maybe monitored using fluoroscopy or any other appropriate imagingmechanism. The driving mechanism may include pressurized saline or otherhydraulic fluid that is pressurized through the endoscopic cathetershaft. Thus, very precise control may be accomplished.

FIG. 4 shows a fastener or implant 250. The fastener 250 includesfeatures in common with the other fasteners disclosed herein and may beused in conjunction with any of the other fastening applicationsdescribed herein. However, the fastener 250 includes a corrugated body251. The body 251 includes grooves 253 that extend axially along thelength of the body 251. Thus, extending circumferentially around thebody 251, a plurality of grooves 253 alternate with a plurality ofridges 255. Further, the fastener body 251 includes a pair of splitportions or clevises 257 and 258. The split portions are formed byrespective splits or cuts 259 into the body 251. In this regard, thesplits 259 may be formed by making a cut radially into the body 251 andextending in an axial direction. Thus, the two split portions 257 and258 are attached to the remainder of the body 251 at a distal positionand extend proximally to free ends. The free ends include a plurality ofsharp protrusions along a curved surface. These points are formed due tothe corrugations. In particular, the ridges 255 form the sharpprotrusions, as illustrated in the inset partial side view in FIG. 4,which are advantageous for gripping tissue and preventing distal slidingof the fastener 250. Although each split portion 257 and 258 includesthree such protrusions as illustrated, it should be understood that thefastener 250 may be designed such that one or more of the split portionshas any other number of protrusions, including a single sharpprotrusion. For example, if a larger number of sharp protrusions aredesired, the body 251 could be more densely corrugated (i.e., a greaternumber of alternating grooves 253 and ridges 255 could be provided)and/or the angle of the cut or slice could be adjusted. Further, thelength of proximal extension of the projections may be adjusted byvarying the depth of the grooves 253 with respect to the ridges 255.

The split portions 257 and 258 do not substantially impede distalinsertion into tissue but resist proximal movement from an insertionlocation by engaging the tissue. It has been discovered that thecombination of the pointed and/or sharp-edged proximal ends of the splitportions 257 and 258 with the alternating ridges on the proximal end ofthe split portions creates improved performance.

Further, the split portions or wings 257 and 258 are axially offset fromeach other. For example, split 257 is axially located at position aalong axis x and split 258 is axially located at position b along axisx. This allows for greater structural strength of the other portions ofthe body 251 as compared to a non-offset configuration. In particular,since the cuts progress continually radially inward as they progressdistally, a non-offset portion would have a substantially smaller amountof material in cross-section in the distal end of the cut. This wouldlead to a mechanically weak point or region along the axis of the bodyand could lead to mechanical failure, especially in fasteners of smalldimensions.

The distal tip of the fastener 250 is pyramidal, with a sharp point, anda plurality of surfaces separated by edges that converge at the sharppoint. Although four planar surfaces are provided, it should beappreciated that any appropriate suitable number of surfaces may beprovided and that one or more or all of the surfaces may be non-planar.

The fastener 250 also includes a hooked end portion 260. The hookedportion may be suitable for coupling any other temporary and/orpermanent implant.

The fastener 250 may be produced by first forming the body 251 with thecorrugations, e.g., by injection molding or extrusion, and subsequentlyforming clevises 257 and 258, e.g., by cutting radially into the side ofthe body 251. As illustrated, the cut is curved, with an angle (at theproximal entry point), relative to the longitudinal axis of the body251, that gradually decreases from the proximal initial cutting locationtoward the distal end of the fastener 250 and eventually becominglinear. Although the split or cut of the illustrated example is madewith a curved or varying angle with respect to the longitudinal axis ofthe body 251, it should be understood that any appropriate cut,including a linear cut, may be made.

Although the fastener 250 includes two wings or split portions spacedequally around the radial periphery of the body 251, it should beappreciated that any number of clevises, including a single clevis maybe provided and at any appropriate spacing around the radial periphery.

Furthermore, it should be understood that the corrugated split-bodiedconfiguration may be employed in combination with any of the otherfastener features disclosed herein. For example, the fastener 250 mayhave a split corrugated distal portion and a threaded proximal portionconfigured to receive a proximal head as disclosed in greater detailabove, and/or include filaments in addition to the split portions.

FIGS. 5A and 5B illustrate a surgical micro implant or fastener 900.FIG. 5B is a cross-sectional view of the surgical implant 900 with across-sectional plane extending along and including the longitudinalaxis of the fastener 900 of FIG. 5A. The fastener 900 includes manyfeature of the other example fasteners described herein. Further, thefastener includes a filament/suture 950 extending proximally from aproximal end of the fastener body 905. In this regard, when a driverfires the fastener 900, e.g., by application a saline or other precisehydraulic force or any other appropriate mechanism, the depth to whichthe fastener 900 is driven is limited by the amount of slack in thesuture 950. This may be accomplished by fixing a proximal end and/orother proximal portion of the suture 950 to a structure, e.g., a fixedposition within the driver device, with a predetermined length and/orslack between the fixing location and the fastener body 905.

Referring to the cross-sectional view of FIG. 5B, the suture 950 mayextend longitudinally into an interior location of the fastener head905. An example manufacturing method may include molding, coextruding,or otherwise forming the fastener head 905 over the suture 950.Coextrusion may be particularly advantageous. It should be appreciatedhowever, that any appropriate manufacturing method may be employed.Further, although a suture 950 of non-stretchable material is provided,it should be understood that other materials, e.g., stretchablematerials, may be provided. However, it may be preferable that, even ifstretchable, the material have a predeterminable extension limit forparticular driving momentums and/or applications. Further, a braided,non-braided, mono-filament, and/or multi-filament material may beprovided.

Although the fastener 900 includes micro filaments to anchor into atissue and resist proximal dislocation after implantation, it should beunderstood that any other anchoring mechanism, e.g., wings or splitportions as described above, may be provided. Moreover, any of thefeatures disclosed with regard to the other example fasteners disclosedherein may be provided in conjunction with the fastener 900.

FIGS. 6A to 6C schematically and sequentially illustrate the bringinginto apposition of two tissues using a surgical implant 1300, whichshares many features in common with the other implants described herein.Implant 1300 has a distal anchoring portion with micro filaments and aproximal threaded portion configured to mate with an internally threadedhead 1325, analogous to the implant 200 described above. Implant 1300also includes a proximally extending filament/suture 1350, analogous tothe implant 900 described above.

Referring to FIGS. 6A and 6B, a surgical system 1200 includes ahandpiece 1202 configured to drive the fastener 1300 to a predetermineddepth. The depth is limited, e.g., by a predetermined amount of slack inthe suture 1350. The proximal end of the suture 1350 is attached to acapstan 1205 configured to adjust the length of the suture 1350extending from capstan 1205. In this regard, the capstan 1205, which maybe actuated by a motor system or any other appropriate mechanism, mayset the slack by reeling off a predetermined length of suture 1350 priorto driving the fastener 1300 and/or the capstan 1205 may have apredetermined amount of allowed rotation such that driving of thefastener 1300 causes the capstan 1205 to rotate only the predeterminedamount, thereby setting the driving depth of the fastener 1300. Thedetermination of the depth and/or the driving velocity of the fastener1300 may be determined in a processor 1210 of the handpiece 1202.Although the processing takes place in a processor 1210 located in thehandpiece 1202, it should be understood that the processor may bedisposed in other parts of the device, e.g., in the shaft 1215 and/orthe processing may take place at a location separate from the handpiece1202 and shaft 1215, e.g., at a remote computing unit thatcommunications, e.g., wirelessly, with the surgical device. Further, itshould be understood that the capstan 1210 may be disposed in the shaft1215.

Using any appropriate location determining mechanism, e.g., an imagingmechanism such as a fluoroscopy or ultrasound imaging unit, which may belocated in the handpiece 1202, shaft 1215 and/or an external device, thesystem 1200 determines the location of the first layer of tissue 980 andthe second layer of tissue 990. Depending on the application, it may besufficient for the system 1200 to determine just the respectivelocations of the tissues 980 and 990. The location may be an approximatelocation of the center of the tissue or a face, e.g., a proximal face,of each tissue. In the illustrated example, the system determines, e.g.,via the imaging device and/or the processor 1210, the respectivepositions of a first or proximal face 981 of the first tissue 980, asecond or distal face 982 of the first tissue 980, a first or proximalface 991 of the second tissue 990, and a second or distal face 992 ofthe second tissue 990 taken along the line or approximately along theline that the fastener 1300 is to be driven. Based on these positionalvalues, the processor 1210 may determine the thickness of each tissue980, 990 and the space between the distal face 982 of the first tissue980 and the proximal face 991 of the second tissue, in addition to thelocation of each of the distal and proximal faces. Based on the thesevalues, or a portion thereof, the system 1200, e.g., via processor 1210,calculates a precise distance and velocity to drive the fastener. Thesystem 1200 may also take into account the features of the particularfastener being driven (e.g., dimensions, mass, and/or coefficient offriction) and/or the hardness and/or density of the tissue, which may beapproximated, e.g., where the tissue is of a known or expected densityand/or hardness, or determined based on the imaging data, e.g.,fluoroscopy data. The velocity and/or distance may optionally befacilitated by incorporating empirical data into the algorithm or purelybased. The depth is controlled, e.g., by precisely controlling thelength of suture 1350 via the capstan 1215. The velocity is preciselycontrolled, e.g., by a hydraulic driver, e.g., a saline driver.

Where the shaft 1215 abuts the first or proximal face 981 of the tissue980, position of the first or proximal face 981 of the tissue 980 may bedetermined without using imaging.

As illustrated in FIG. 6A, after the shaft 1215 is placed adjacent theproximal face 981 of the first tissue 980 and the precise drivingvelocity and depth/position are determined, e.g., by processor 1210 inthe handpiece 1205, the system 1200 drives the fastener 1300 in theproximal direction indicated by arrow 1250 through the first tissue 980across any gap between the first and second tissues 980 and 990, andinto the second tissue 990, where the fastener 1300 anchors againstdistal retraction from the second tissue 990.

Referring to FIG. 6B, the capstan 1210 is then actuated, e.g., by amotor system controlled by, e.g., processor 1210, to proximally reel thesuture 1350, thereby drawing the fastener 1300, along with the tissue990 to which it is anchored, proximally toward the shaft 1215 and thefirst tissue 980 adjacent the shaft 1215. The proximal direction ofmovement is indicated by arrow 1260 in FIG. 6B. The first tissue 980 isrestrained from proximal movement by, e.g., contact with the distal endof the shaft 1215.

As also illustrated in FIG. 6B the proximal head, or threaded nut, 1325is moved distally, e.g., by a rotatable driver. The distal direction ofmovement is illustrated by arrow 1250 in FIG. 6B. The proximal head 1325may be moved distally at any point after the anchoring fastener 1300 isdriven from the shaft 1215. Once the fastener is pulled a sufficientproximal distance, the threaded proximal portion of the body of thefastener 1300 protrudes through the proximal face 981 of the firsttissue 980. The proximal head 1325 is then coupled to the threadedportion to form a threaded connection. A rotatable driver then rotatesthe head 1325 to distally drive the head 1325 to its implanted position,illustrated in FIG. 6C. It should be understood than any final portionof the gap between the distal face 982 of the first tissue and theproximal face 991 of the second tissue 990 may be taken up by continuingto reel in the suture 1350 and/or driving the proximal head 1325 in thedistal direction along the threads of the body of the fastener 1300.

After the proximal head 1325 has been fully driven on the threaded shaftof the fastener 1300, the suture 1350, or a portion thereof, may beseparated from the fastener 1300, e.g., by cutting. In this regard, thesystem 1200 may include a cutter or other trimming device, e.g., at thedistal end of the shaft 1215, in order to cut the suture 1350. Inapplications where there is an undesired excess length of externallythreaded shaft of the fastener 1300 extending proximally from the fullydriven proximal head 1325, the system 1200 may provide for trimming someor all of the excess. In this regard, the system may include a cutter orother trimming device, e.g., at the distal end of the shaft 1215, whichmay be the same or different than the cutter for the suture 1350, inorder to remove some or all of the excess.

Further although two tissues 980 and 990 are illustrated in FIGS. 6A to6C, it should be understood that the fastener may be driven through anydesired number of tissue layers before reaching its anchored position.Moreover, any other example fasteners described herein may be formedwith a suture and used in analogous manner to the fastener 1300.

During the procedure illustrated in FIGS. 6A to 6C, the system 1200 mayhydraulically drive the implant 1300 or use any other appropriatedriving mechanism. Regarding hydraulic delivery, it is noted that a veryprecise force may be delivered at the distal end portion of the shaft1215 to drive the fastener 1300. This force may be controlled by theprocessor 1210 in connection with hydraulics, e.g., in the handpiece.For example, the hydraulic fluid, e.g., saline, may be disposed in atube extending along the shaft 1215. hydraulics and controls in thehandpiece 1202 may then transmit a very precise force, via the hydraulicfluid extending along the shaft 1215, to the distal end portion of theshaft 1215 to precisely drive the fastener 1300.

FIG. 7 is an illustration of a surgical implant 1000. The fastener 1000includes many feature of the other example fasteners described herein.Further, the fastener 1000 includes a proximal portion having aratcheting mechanism including a micro ratcheting head 1025 and ratchetteeth 1030. The ratcheting mechanism of the implant 1000 performs afunction analogous to that of the micro threaded arrangement of thefastener 200 described above. However, as opposed to rotation of thehead 225 about the threads 230 of the fastener 200, the ratcheting head1025 slides, e.g., linearly, along the fastener body 1005. As eachratchet tooth 1030 or circumferential set of ratchet teeth 1030 isdistally traversed, the proximal retraction of the head 1025 is resistedor prevented by the ratcheting engagement of a proximal surface of thehead 1025 with a distal surface of the ratcheting tooth or teeth 1030.In this regard, for each axial ratcheting position of the head 1025, thefastener body 1005 may have any appropriate number of ratcheting teeth1030, including a single ratcheting tooth 1030, arranged to engage theratcheting head 1025. Further, a single tooth 1030 may extendcontinuously around the entire radial periphery of the fastener body1005.

Although the fastener 1000 includes micro filaments to anchor into atissue and resist proximal dislocation after implantation, it should beunderstood that any other anchoring mechanism, e.g., wings or splitportions as described above, may be provided. Moreover, any of thefeatures disclosed with regard to the other example fasteners disclosedherein may be provided in conjunction with the fastener 1000.

FIG. 8 is an illustration of a distal end portion of a surgical implant1100. This distal arrangement may be provided on the distal end of anyexample fastener disclosed herein. The distal arrangement includes threeconcave surfaces 1105 that distally converge to form a sharp point 1110.Separating the three concave surfaces 1105 are three tapered cuttingedges 1115. These tapered cutting edges 1115 may facilitate penetrationof tissue, e.g., soft tissue. Although the end portion illustrated inFIG. 8 includes three concave surfaces 1105 and separated by threecorresponding tapered cutting edges 1115, it should be understood thatany appropriated number of concave surfaces 1105 and correspondingcutting edges 1115 may be provided.

The various mechanisms described herein provide for a tissue repairsystem that allows great flexibility. For example, smaller defects maybe repairable with a single fastener (e.g., fastener 100 or any otherfastener described herein), and larger defects may be repairable with aplurality of fasteners, with or without a washer or plate 2200, asdescribed above. Larger defects, e.g., hernias or large holes, may bemore suited for a mesh 1300 application, as described above.

The various implants described herein, e.g., fasteners or anchors 100,200, 300, 500, and 700 and/or nuts 225, may be formed by molding, e.g.,injection molding.

Further, any of the implantable elements described herein, e.g.,fasteners 100, 200, 300, 500, and 700 and/or nuts 225, and/or sutures,may be formed wholly or partly of a material absorbable into thepatient's body, or of a non-absorbable material, depending on, e.g., thespecific application. For example, these elements may be formed ofpolyglycolic acid (PGA), or a PGA copolymer. These elements may also, oralternatively, be formed of copolymers of polyester and/or nylon and/orother polymer(s). Moreover, these elements may contain one or moreshape-memory alloys, e.g., nitinol and/or spring-loaded steel.

Absorbable materials may be advantageous where there is a potential formisfiring or improper locating of the various implants. For example, ina situation where a fastening arm 1100 drives a fastener at anunintended location, or where the tissue does not properly receive theimplant, the fastener, e.g., fastener 100, even where not needed, wouldrelatively harmless, as it would eventually absorb into the patient'sbody.

Although the present invention has been described with reference toparticular examples and exemplary embodiments, it should be understoodthat the foregoing description is in no manner limiting. Moreover, thefeatures described herein may be used in any combination.

What is claimed is:
 1. A surgical device, comprising: a fastenerincluding a proximal head having a locking mechanism, an elongated bodyhaving proximally directed anchoring filaments and a correspondinglocking mechanism configured to interlock with the locking mechanism,and a distal tip; a filament secured to the fastener and extendingproximally from a proximal end of the elongated body; a single devicebody; a fastener driver coupled to the single device body and configuredto drive the fastener with sufficient impulse through a firstunsupported soft tissue or prosthesis and into a second unsupported softtissue, anchoring the fastener within the second soft tissue; and aretraction mechanism coupled to the single device body and configured toproximally reel the filament after the fastener has been driven by thefastener driver of the single device body such that the secondunsupported soft tissue is drawn towards the first unsupported softtissue or prosthesis, the retraction mechanism being configured to applya sufficient retraction force utilizing the proximal head to thefastener to bring the elongated body into the proximal head therebyengaging the locking mechanism of the proximal head to the correspondinglocking mechanism of the elongated body and bringing a proximal surfaceof the second unsupported soft tissue in direct apposition to a distalsurface of the first unsupported soft tissue or prosthesis.
 2. Thesurgical device of claim 1, wherein the fastener driver is configured todrive the fastener at a predetermined distance and velocity based on adetermined distance between the first tissue or prosthesis and thesecond tissue.
 3. The surgical device of claim 2, wherein the fastenerdriver is adjustable to drive the fastener at different distances andvelocities based on the determined distances between the first tissue orprosthesis and the second tissue.
 4. The surgical device of claim 1,wherein the fastener driver is configured to impart a momentum to thefastener sufficient to drive the fastener through the first soft tissueor prosthesis and into the second soft tissue.
 5. The surgical device ofclaim 4, wherein the fastener driver is configured to transfer hydraulicforce to the fastener to impart the momentum.
 6. The surgical device ofclaim 5, wherein saline is provided for hydraulic propulsion.
 7. Thesurgical device of claim 1, wherein the anchoring filaments of thefastener are configured to resist proximal movement of the fastener whenthe fastener is driven through the first soft tissue or prosthesis andinto the second soft tissue.
 8. The surgical device of claim 1, whereinthe fastener driver includes a plurality of flanges configured tocontact a distal face of the proximal head to limit the depth to whichthe fastener is driven by the fastener driver.
 9. The surgical device ofclaim 8, wherein the flanges are radially expandable from each other torelease the proximal head of the fastener.
 10. The surgical device ofclaim 1, wherein the filament is a suture attached to the fastener. 11.A surgical device, comprising: a fastener including a proximal end, aproximal head having a locking mechanism, an elongated body having acorresponding locking mechanism configured to interlock with the lockingmechanism, and a distal tip; a filament secured to the fastener andextending proximally from a proximal end of the elongated body; and afastener driver coupled to a single device body and configured todistally drive the fastener with sufficient impulse through a firstunsupported soft tissue or prosthesis and into a second unsupported softtissue such that the fastener anchors within the second unsupported softtissue; and a retraction mechanism coupled to the single device body andconfigured to proximally reel the filament after the fastener has beendriven by the fastener driver of the single device body such that thesecond unsupported soft tissue is drawn towards the first unsupportedsoft tissue or prosthesis, the retraction mechanism being configured toapply a sufficient retraction force utilizing the proximal head to thefastener to bring the elongated body into the proximal head therebyengaging the locking mechanism of the proximal head to the correspondinglocking mechanism of the elongated body and bringing a proximal surfaceof the second unsupported soft tissue in direct apposition to a distalsurface of the first unsupported soft tissue or prosthesis.
 12. Thedevice of claim 11, wherein the filament is a braided filament.
 13. Thesurgical device of claim 11, wherein the distance to which the fasteneris driven is limited by a predetermined amount of slack in the filamentprior to the driving, the distance being limited by the tautening of thefilament.
 14. The device of claim 11, wherein the fastener includesproximally extending anchoring filaments configured to anchor thefastener into the second tissue.
 15. The surgical device of claim 11,the fastener driver being configured to impart a momentum to thefastener sufficient to drive the fastener through the first soft tissueand into the second soft tissue when the second soft tissue isunsupported.
 16. The surgical device of claim 11, wherein the fastenerdriver is configured to drive the fastener at a predetermined distanceand velocity based on a determined distance between the first tissue orprosthesis and the second tissue.
 17. The surgical device of claim 16,wherein the fastener driver is adjustable to drive the fastener atdifferent distances and velocities based on the determined distancesbetween the first tissue or prosthesis and the second tissue.
 18. Thesurgical device of claim 11, wherein the fastener driver is configuredto drive the fastener using a hydraulic propulsion.
 19. The surgicaldevice of claim 18, wherein saline is provided for the hydraulicpropulsion.
 20. The surgical device of claim 11, wherein the retractionmechanism comprises a capstan configured to proximally reel the filamentafter the fastener has been driven by the fastener driver.
 21. Thesurgical device of claim 20, wherein the proximal reeling of thefilament causes a corresponding proximal movement of the second tissuewhen the fastener is anchored in the second tissue.
 22. The surgicaldevice of claim 11 wherein the fastener is molded to the filament. 23.The surgical device of claim 22, wherein the fastener is coextruded withthe filament.
 24. The surgical device of claim 23, wherein the filamentis a braided filament.
 25. The surgical device of claim 11, wherein thefastener includes a plurality of molded radially disposed anchoringfilaments.
 26. The surgical device of claim 11, wherein the retractionmechanism comprises a capstan configured to proximally reel the filamentafter the fastener has been driven by the fastener driver such that thesecond tissue is drawn to the first tissue or prosthesis.
 27. Thesurgical device of claim 11, wherein the fastener further includes: aproximal threaded portion; wherein the proximal head is internallythreaded and configured to mate with the threaded portion of thefastener.
 28. The surgical device of claim 27, wherein the retractionmechanism comprises a capstan configured to proximally reel the filamentafter the fastener has been driven by the fastener driver such that thesecond tissue is drawn towards the first tissue or prosthesis.
 29. Thesurgical device of claim 28, wherein the proximal head is coupled to thethreaded portion of the fastener such that any remaining gap between thesecond tissue and the first tissue or prosthesis is closed.